Trial Outcomes & Findings for A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (NCT NCT03337698)

NCT ID: NCT03337698

Last Updated: 2026-05-12

Results Overview

OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions, ≥4 weeks apart, during Stage 1 as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2 (S1C2): Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

314 participants

Primary outcome timeframe

Up to 50.4 months

Results posted on

2026-05-12

Participant Flow

A total of 314 participants with metastatic non-small cell lung cancer (NSCLC) took part in the study from 27 Dec 2017 to 25 Nov 2025. The study had 2 cohorts: Cohort 1: participants with no prior systemic therapy for metastatic NSCLC \& Cohort 2: participants with 1 prior line of systemic therapy for NSCLC. Multiple combination therapies were compared against common control(s) in Cohorts 1 and 2.

Eligible participants were assigned to 1 of several treatment arms in Stage 1. Participants with PD, loss of clinical benefit, or unacceptable toxicity in Stage 1 were eligible for a different treatment combination in Stage 2. Participants in Stage 1 who did not enter Stage 2 \& those who completed Stage 2 treatment entered the long-term survival follow-up. Results include only those cohorts that enrolled participants; planned cohorts that were never opened for enrollment are not presented.

Participant milestones

Participant milestones
Measure
Stage 1 Cohort 1: Control (Atezolizumab)
Participants received atezolizumab 1200 milligrams (mg), intravenous (IV) infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, orally (PO), once daily (QD) on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Cibisatamab (CEA-TCB)
Participants received atezolizumab 1200 mg, IV on Day 1 and carcinoembryonic antigen - T-cell bispecific antibody \[CEA-TCB\] 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until disease progression (PD), loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
Stage 1 Cohort 2: Control (Docetaxel)
Participants received docetaxel 75 milligrams per square meter (mg/m\^2), IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CPI-444
Participants received CPI-444 100 mg, PO, twice daily (BID), on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Docetaxel + Atezolizumab
Participants received docetaxel 75 mg/m\^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Idasanutlin + Docetaxel
Participants received idasanutlin 150 mg, PO, QD on Days 1-5 of each cycle and docetaxel 50 mg/m\^2, IV infusion on Days 1 and 15 of each cycle until PD or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 milligrams per kilogram (mg/kg), IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Sacituzumab Govitecan (SG)
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Evolocumab
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Camonsertib
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 2 Cohort 1: Carboplatin + Pemetrexed + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m\^2, IV infusions on Day 1 of each cycle and carboplatin area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Docetaxel + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m\^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Atezolizumab + Linagliptin
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1
STARTED
3
5
1
1
66
15
1
16
18
31
1
41
45
30
32
8
0
0
0
Stage 1
Safety-evaluable Population
3
5
1
1
61
15
1
15
16
30
0
40
43
30
31
8
0
0
0
Long-term Survival Follow-up
STARTED
1
4
0
1
36
9
1
9
11
20
0
26
28
20
30
5
2
28
19
Stage 1
COMPLETED
1
5
1
1
52
10
1
12
13
29
0
37
34
28
31
7
0
0
0
Stage 1
NOT COMPLETED
2
0
0
0
14
5
0
4
5
2
1
4
11
2
1
1
0
0
0
Stage 2
STARTED
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2
33
22
Stage 2
Safety-evaluable Population
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2
32
20
Stage 2
COMPLETED
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2
28
19
Stage 2
NOT COMPLETED
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5
3
Long-term Survival Follow-up
COMPLETED
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Long-term Survival Follow-up
NOT COMPLETED
1
4
0
1
36
9
1
9
11
20
0
26
28
20
30
5
2
28
19

Reasons for withdrawal

Reasons for withdrawal
Measure
Stage 1 Cohort 1: Control (Atezolizumab)
Participants received atezolizumab 1200 milligrams (mg), intravenous (IV) infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, orally (PO), once daily (QD) on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Cibisatamab (CEA-TCB)
Participants received atezolizumab 1200 mg, IV on Day 1 and carcinoembryonic antigen - T-cell bispecific antibody \[CEA-TCB\] 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until disease progression (PD), loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
Stage 1 Cohort 2: Control (Docetaxel)
Participants received docetaxel 75 milligrams per square meter (mg/m\^2), IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CPI-444
Participants received CPI-444 100 mg, PO, twice daily (BID), on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Docetaxel + Atezolizumab
Participants received docetaxel 75 mg/m\^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Idasanutlin + Docetaxel
Participants received idasanutlin 150 mg, PO, QD on Days 1-5 of each cycle and docetaxel 50 mg/m\^2, IV infusion on Days 1 and 15 of each cycle until PD or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 milligrams per kilogram (mg/kg), IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Sacituzumab Govitecan (SG)
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Evolocumab
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Camonsertib
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 2 Cohort 1: Carboplatin + Pemetrexed + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m\^2, IV infusions on Day 1 of each cycle and carboplatin area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Docetaxel + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m\^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Atezolizumab + Linagliptin
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1
Progressive Disease
0
0
0
0
0
1
0
1
0
0
0
0
0
0
0
0
0
0
0
Stage 1
Protocol Violation
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
Stage 1
Physician Decision
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
Stage 1
Death
2
0
0
0
4
2
0
3
2
0
0
3
4
1
0
1
0
0
0
Stage 1
Withdrawal by Subject
0
0
0
0
10
2
0
0
3
1
1
0
1
0
1
0
0
0
0
Stage 1
Study Terminated by Sponsor
0
0
0
0
0
0
0
0
0
0
0
1
5
1
0
0
0
0
0
Stage 2
Study Terminated by Sponsor
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
Stage 2
Death
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5
2
Long-term Survival Follow-up
Arm Terminated by Sponsor
0
0
0
0
0
0
0
1
2
3
0
0
0
0
0
0
0
0
0
Long-term Survival Follow-up
Reason not Specified
0
0
0
0
0
0
0
0
0
0
0
0
2
0
0
0
1
0
1
Long-term Survival Follow-up
Study Terminated by Sponsor
0
0
0
0
1
0
0
0
0
0
0
4
5
0
0
3
0
2
0
Long-term Survival Follow-up
Withdrawal by Subject
0
1
0
0
6
2
0
2
1
3
0
2
2
1
4
0
1
0
0
Long-term Survival Follow-up
Lost to Follow-up
0
0
0
0
0
0
0
0
0
0
0
1
2
1
1
0
0
2
1
Long-term Survival Follow-up
Death
1
3
0
1
29
7
1
6
8
14
0
19
17
18
25
2
0
24
17

Baseline Characteristics

Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Stage 1 Cohort 1: Control (Atezolizumab)
n=3 Participants
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
n=5 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
n=1 Participants
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
Stage 1 Cohort 2: Control (Docetaxel)
n=66 Participants
Participants received docetaxel 75 mg/m\^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=15 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CPI-444
n=16 Participants
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Docetaxel + Atezolizumab
n=18 Participants
Participants received docetaxel 75 mg/m\^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
n=31 Participants
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Idasanutlin + Docetaxel
n=1 Participants
Participants received idasanutlin 150 mg, PO, QD on Days 1-5 of each cycle and docetaxel 50 mg/m\^2, IV infusion on Days 1 and 15 of each cycle until PD or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
n=41 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy
n=45 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + SG
n=30 Participants
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Evolocumab
n=32 Participants
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Camonsertib
n=8 Participants
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 2 Cohort 1: Carboplatin + Pemetrexed + Atezolizumab
n=2 Participants
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m\^2, IV infusions on Day 1 of each cycle and carboplatin AUC 6 mg/mL/min (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Docetaxel + Atezolizumab
n=33 Participants
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m\^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Atezolizumab + Linagliptin
n=22 Participants
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Total
n=371 Participants
Total of all reporting groups
Age, Categorical
Stage 1 · <=18 years
0 Participants
n=3 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=66 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=31 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=41 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=45 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=30 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=32 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=8 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=314 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Age, Categorical
Stage 1 · Between 18 and 65 years
0 Participants
n=3 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
2 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
35 Participants
n=66 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
13 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
11 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
8 Participants
n=18 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
16 Participants
n=31 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
23 Participants
n=41 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
17 Participants
n=45 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
13 Participants
n=30 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
9 Participants
n=32 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
6 Participants
n=8 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
154 Participants
n=314 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Age, Categorical
Stage 1 · >=65 years
3 Participants
n=3 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
3 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
31 Participants
n=66 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
2 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
5 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
10 Participants
n=18 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
15 Participants
n=31 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
18 Participants
n=41 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
28 Participants
n=45 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
17 Participants
n=30 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
23 Participants
n=32 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
2 Participants
n=8 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
160 Participants
n=314 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Age, Categorical
Stage 2 · <=18 years
0 Participants
n=2 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=33 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=22 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=57 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Age, Categorical
Stage 2 · Between 18 and 65 years
0 Participants
n=2 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
20 Participants
n=33 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
12 Participants
n=22 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
32 Participants
n=57 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Age, Categorical
Stage 2 · >=65 years
2 Participants
n=2 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
13 Participants
n=33 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
10 Participants
n=22 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
25 Participants
n=57 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Sex: Female, Male
Stage 1 · Female
1 Participants
n=3 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
18 Participants
n=66 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
5 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
7 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
6 Participants
n=18 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
8 Participants
n=31 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
10 Participants
n=41 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
11 Participants
n=45 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
8 Participants
n=30 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
9 Participants
n=32 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=8 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
86 Participants
n=314 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Sex: Female, Male
Stage 1 · Male
2 Participants
n=3 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
4 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
48 Participants
n=66 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
10 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
9 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
12 Participants
n=18 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
23 Participants
n=31 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
31 Participants
n=41 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
34 Participants
n=45 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
22 Participants
n=30 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
23 Participants
n=32 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
7 Participants
n=8 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
228 Participants
n=314 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Sex: Female, Male
Stage 2 · Female
0 Participants
n=2 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
9 Participants
n=33 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
6 Participants
n=22 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
15 Participants
n=57 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Sex: Female, Male
Stage 2 · Male
2 Participants
n=2 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
24 Participants
n=33 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
16 Participants
n=22 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
42 Participants
n=57 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Ethnicity (NIH/OMB)
Stage 1 · Hispanic or Latino
0 Participants
n=3 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
2 Participants
n=66 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=31 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=41 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=45 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
2 Participants
n=30 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=32 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=8 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
5 Participants
n=314 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Ethnicity (NIH/OMB)
Stage 1 · Not Hispanic or Latino
3 Participants
n=3 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
5 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
50 Participants
n=66 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
14 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
15 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
13 Participants
n=18 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
19 Participants
n=31 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
27 Participants
n=41 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
31 Participants
n=45 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
21 Participants
n=30 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
20 Participants
n=32 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
6 Participants
n=8 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
228 Participants
n=314 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Ethnicity (NIH/OMB)
Stage 1 · Unknown or Not Reported
0 Participants
n=3 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
14 Participants
n=66 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
5 Participants
n=18 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
12 Participants
n=31 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
13 Participants
n=41 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
14 Participants
n=45 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
7 Participants
n=30 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
12 Participants
n=32 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
2 Participants
n=8 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
81 Participants
n=314 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Ethnicity (NIH/OMB)
Stage 2 · Hispanic or Latino
0 Participants
n=2 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=33 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
2 Participants
n=22 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
3 Participants
n=57 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Ethnicity (NIH/OMB)
Stage 2 · Not Hispanic or Latino
2 Participants
n=2 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
22 Participants
n=33 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
16 Participants
n=22 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
40 Participants
n=57 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Ethnicity (NIH/OMB)
Stage 2 · Unknown or Not Reported
0 Participants
n=2 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
10 Participants
n=33 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
4 Participants
n=22 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
14 Participants
n=57 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Race (NIH/OMB)
Stage 1 · American Indian or Alaska Native
0 Participants
n=3 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=66 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=31 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=41 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=45 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=30 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=32 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=8 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=314 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Race (NIH/OMB)
Stage 1 · Asian
1 Participants
n=3 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
3 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
15 Participants
n=66 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
8 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
4 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
2 Participants
n=18 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
7 Participants
n=31 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
5 Participants
n=41 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
14 Participants
n=45 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
5 Participants
n=30 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
9 Participants
n=32 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
3 Participants
n=8 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
77 Participants
n=314 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Race (NIH/OMB)
Stage 1 · Native Hawaiian or Other Pacific Islander
0 Participants
n=3 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=66 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=31 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=41 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=45 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=30 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=32 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=8 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=314 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Race (NIH/OMB)
Stage 1 · Black or African American
0 Participants
n=3 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=66 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=31 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=41 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=45 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=30 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=32 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=8 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
2 Participants
n=314 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Race (NIH/OMB)
Stage 1 · White
2 Participants
n=3 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
2 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
38 Participants
n=66 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
5 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
9 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
11 Participants
n=18 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
14 Participants
n=31 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
27 Participants
n=41 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
18 Participants
n=45 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
19 Participants
n=30 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
11 Participants
n=32 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
3 Participants
n=8 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
162 Participants
n=314 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Race (NIH/OMB)
Stage 1 · More than one race
0 Participants
n=3 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=66 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=31 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=41 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=45 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=30 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=32 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=8 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=314 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Race (NIH/OMB)
Stage 1 · Unknown or Not Reported
0 Participants
n=3 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
13 Participants
n=66 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
5 Participants
n=18 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
10 Participants
n=31 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=1 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
9 Participants
n=41 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
13 Participants
n=45 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
6 Participants
n=30 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
12 Participants
n=32 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
2 Participants
n=8 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
72 Participants
n=314 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Race (NIH/OMB)
Stage 2 · American Indian or Alaska Native
0 Participants
n=2 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=33 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=22 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=57 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Race (NIH/OMB)
Stage 2 · Asian
1 Participants
n=2 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=33 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=22 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
2 Participants
n=57 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Race (NIH/OMB)
Stage 2 · Native Hawaiian or Other Pacific Islander
0 Participants
n=2 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=33 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=22 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=57 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Race (NIH/OMB)
Stage 2 · Black or African American
0 Participants
n=2 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=33 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=22 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
1 Participants
n=57 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Race (NIH/OMB)
Stage 2 · White
1 Participants
n=2 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
24 Participants
n=33 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
18 Participants
n=22 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
43 Participants
n=57 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Race (NIH/OMB)
Stage 2 · More than one race
0 Participants
n=2 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=33 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=22 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
0 Participants
n=57 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Race (NIH/OMB)
Stage 2 · Unknown or Not Reported
0 Participants
n=2 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
8 Participants
n=33 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
3 Participants
n=22 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
11 Participants
n=57 Participants • Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.

PRIMARY outcome

Timeframe: Up to 50.4 months

Population: Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen. Cohort 1 with 'Atezolizumab (control arm)' was closed during the study conduct and was reactivated with 'Atezo + Tira' as a new comparator arm. Comparative statistics are not presented for Atezo + Tira arm \& Atezo + CEA-TCB arms (Cohorts 1 \& 2) due to the small sample size (N=1), which precludes any meaningful conclusion.

OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions, ≥4 weeks apart, during Stage 1 as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2 (S1C2): Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

Outcome measures

Outcome measures
Measure
Stage 1 Cohort 1: Control (Atezolizumab)
n=3 Participants
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Control (Docetaxel)
n=61 Participants
Participants received docetaxel 75 mg/m\^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
n=5 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
n=1 Participants
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=15 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CPI-444
n=15 Participants
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Docetaxel + Atezolizumab
n=16 Participants
Participants received docetaxel 75 mg/m\^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
n=30 Participants
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
n=40 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy
n=36 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + SG
n=30 Participants
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Evolocumab
n=31 Participants
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Camonsertib
n=8 Participants
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 2 Cohort 1: Carboplatin + Pemetrexed + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m\^2, IV infusions on Day 1 of each cycle and carboplatin AUC 6 mg/mL/min (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Docetaxel + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m\^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Atezolizumab + Linagliptin
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: Percentage of Participants With Objective Response (OR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
33.3 percentage of participants
Interval 0.84 to 90.57
13.1 percentage of participants
Interval 5.84 to 24.22
0 percentage of participants
Interval 0.0 to 52.18
100 percentage of participants
Interval 2.5 to 100.0
0 percentage of participants
Interval 0.0 to 97.5
0 percentage of participants
Interval 0.0 to 21.8
0 percentage of participants
Interval 0.0 to 97.5
6.7 percentage of participants
Interval 0.17 to 31.95
6.3 percentage of participants
Interval 0.16 to 30.23
6.7 percentage of participants
Interval 0.82 to 22.07
20.0 percentage of participants
Interval 9.05 to 35.65
16.7 percentage of participants
Interval 6.37 to 32.81
6.7 percentage of participants
Interval 0.82 to 22.07
3.2 percentage of participants
Interval 0.08 to 16.7
0 percentage of participants
Interval 0.0 to 36.94

SECONDARY outcome

Timeframe: From randomization to the first occurrence of PD or death (Up to 48.6 months)

Population: Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen. Cohort 1 with 'Atezolizumab (control arm)' was closed during the study conduct and was reactivated with "Atezo + Tira" as a new comparator arm. Comparative statistics are not presented for Atezo + Tira arm \& Atezo + CEA-TCB arms (Cohorts 1 \& 2) due to the small sample size (N=1), which precludes any meaningful conclusion.

PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. Kaplan-Meier (K-M) method was used to estimate PFS. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

Outcome measures

Outcome measures
Measure
Stage 1 Cohort 1: Control (Atezolizumab)
n=3 Participants
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Control (Docetaxel)
n=61 Participants
Participants received docetaxel 75 mg/m\^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
n=5 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
n=1 Participants
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=15 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CPI-444
n=15 Participants
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Docetaxel + Atezolizumab
n=16 Participants
Participants received docetaxel 75 mg/m\^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
n=30 Participants
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
n=40 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy
n=36 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + SG
n=30 Participants
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Evolocumab
n=31 Participants
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Camonsertib
n=8 Participants
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 2 Cohort 1: Carboplatin + Pemetrexed + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m\^2, IV infusions on Day 1 of each cycle and carboplatin AUC 6 mg/mL/min (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Docetaxel + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m\^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Atezolizumab + Linagliptin
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: Progression-free Survival (PFS) as Determined by Investigator According to RECIST V1.1
1.51 months
Interval 1.31 to
Upper limit of 95% confidence interval (CI) was not estimable due to an insufficient number of participants with events.
4.83 months
Interval 4.11 to 5.91
2.66 months
Interval 0.69 to
Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
6.90 months
95% CI was not estimable due to an insufficient number of participants with events.
1.64 months
95% CI was not estimable due to an insufficient number of participants with events.
2.43 months
Interval 1.84 to 6.77
17.48 months
95% CI was not estimable due to an insufficient number of participants with events.
2.30 months
Interval 1.38 to 5.52
5.09 months
Interval 3.22 to 8.54
2.64 months
Interval 1.71 to 3.98
6.95 months
Interval 4.37 to 8.28
7.93 months
Interval 4.67 to 15.67
5.49 months
Interval 4.27 to 7.16
2.17 months
Interval 1.48 to 4.37
3.50 months
Interval 1.54 to 5.75

SECONDARY outcome

Timeframe: At Month 6

Population: Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen. Cohort 1 with 'Atezolizumab (control arm)' was closed during the study conduct and was reactivated with 'Atezo + Tira' as a new comparator arm. Comparative statistics are not presented for Atezo + Tira arm \& Atezo + CEA-TCB arms (Cohorts 1 \& 2) due to the small sample size (N=1), which precludes any meaningful conclusion.

PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. The KM approach was used to estimate the percentage of participants who were event-free for PFS at Month 6. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

Outcome measures

Outcome measures
Measure
Stage 1 Cohort 1: Control (Atezolizumab)
n=3 Participants
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Control (Docetaxel)
n=61 Participants
Participants received docetaxel 75 mg/m\^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
n=5 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
n=1 Participants
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=15 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CPI-444
n=15 Participants
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Docetaxel + Atezolizumab
n=16 Participants
Participants received docetaxel 75 mg/m\^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
n=30 Participants
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
n=40 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy
n=36 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + SG
n=30 Participants
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Evolocumab
n=31 Participants
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Camonsertib
n=8 Participants
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 2 Cohort 1: Carboplatin + Pemetrexed + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m\^2, IV infusions on Day 1 of each cycle and carboplatin AUC 6 mg/mL/min (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Docetaxel + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m\^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Atezolizumab + Linagliptin
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: PFS Rate at Month 6
33.33 percentage of participants
Interval 0.0 to 86.68
36.79 percentage of participants
Interval 23.61 to 49.96
20.00 percentage of participants
Interval 0.0 to 55.06
100.00 percentage of participants
Interval 100.0 to 100.0
NA percentage of participants
Percentage and 95% CI could not be estimated because the participant was censored prior to 6 months.
29.22 percentage of participants
Interval 3.33 to 55.11
100.00 percentage of participants
Interval 100.0 to 100.0
26.67 percentage of participants
Interval 4.29 to 49.05
37.50 percentage of participants
Interval 13.78 to 61.22
20.00 percentage of participants
Interval 5.69 to 34.31
55.00 percentage of participants
Interval 39.58 to 70.42
61.11 percentage of participants
Interval 45.19 to 77.04
43.33 percentage of participants
Interval 25.6 to 61.07
12.90 percentage of participants
Interval 1.1 to 24.7
12.50 percentage of participants
Interval 0.0 to 35.42

SECONDARY outcome

Timeframe: From randomization to death (Up to 67 months)

Population: Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen. Cohort 1 with 'Atezolizumab (control arm)' was closed during the study conduct and was reactivated with 'Atezo + Tira' as a new comparator arm. Comparative statistics are not presented for Atezo + Tira arm \& Atezo + CEA-TCB arms (Cohorts 1 \& 2) due to the small sample size (N=1), which precludes any meaningful conclusion.

OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. K-M method was used to estimate OS. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

Outcome measures

Outcome measures
Measure
Stage 1 Cohort 1: Control (Atezolizumab)
n=3 Participants
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Control (Docetaxel)
n=61 Participants
Participants received docetaxel 75 mg/m\^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
n=5 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
n=1 Participants
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=15 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CPI-444
n=15 Participants
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Docetaxel + Atezolizumab
n=16 Participants
Participants received docetaxel 75 mg/m\^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
n=30 Participants
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
n=40 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy
n=36 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + SG
n=30 Participants
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Evolocumab
n=31 Participants
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Camonsertib
n=8 Participants
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 2 Cohort 1: Carboplatin + Pemetrexed + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m\^2, IV infusions on Day 1 of each cycle and carboplatin AUC 6 mg/mL/min (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Docetaxel + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m\^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Atezolizumab + Linagliptin
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: Overall Survival (OS)
2.96 months
Interval 2.3 to
Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
9.63 months
Interval 8.34 to 14.78
32.66 months
Interval 10.94 to
Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
NA months
Median and 95% CI were not estimable due to an insufficient number of participants with events.
3.48 months
95% CI was not estimable due to an insufficient number of participants with events.
7.75 months
Interval 1.91 to 16.56
17.48 months
95% CI was not estimable due to an insufficient number of participants with events.
11.53 months
Interval 2.07 to 17.22
9.40 months
Interval 4.63 to 23.59
12.45 months
Interval 5.59 to 15.51
13.70 months
Interval 10.61 to 21.06
16.92 months
Interval 9.76 to 33.71
12.48 months
Interval 7.62 to 17.64
9.10 months
Interval 7.82 to 14.55
NA months
Interval 6.21 to
Median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: At Month 6

Population: Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen. Cohort 1 with 'Atezolizumab (control arm)' was closed during the study conduct and was reactivated with 'Atezo + Tira' as a new comparator arm. Comparative statistics are not presented for Atezo + Tira arm \& Atezo + CEA-TCB arms (Cohorts 1 \& 2) due to the small sample size (N=1), which precludes any meaningful conclusion.

OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at Month 6. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

Outcome measures

Outcome measures
Measure
Stage 1 Cohort 1: Control (Atezolizumab)
n=3 Participants
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Control (Docetaxel)
n=61 Participants
Participants received docetaxel 75 mg/m\^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
n=5 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
n=1 Participants
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=15 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CPI-444
n=15 Participants
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Docetaxel + Atezolizumab
n=16 Participants
Participants received docetaxel 75 mg/m\^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
n=30 Participants
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
n=40 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy
n=36 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + SG
n=30 Participants
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Evolocumab
n=31 Participants
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Camonsertib
n=8 Participants
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 2 Cohort 1: Carboplatin + Pemetrexed + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m\^2, IV infusions on Day 1 of each cycle and carboplatin AUC 6 mg/mL/min (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Docetaxel + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m\^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Atezolizumab + Linagliptin
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: OS Rate at Month 6
33.33 percentage of participants
Interval 0.0 to 86.68
78.34 percentage of participants
Interval 67.47 to 89.2
100.00 percentage of participants
Interval 100.0 to 100.0
100.00 percentage of participants
Interval 100.0 to 100.0
NA percentage of participants
Percentage and 95% CI could not be estimated because the participant was censored prior to 6 months.
53.85 percentage of participants
Interval 26.02 to 81.67
100.00 percentage of participants
Interval 100.0 to 100.0
60.00 percentage of participants
Interval 35.21 to 84.79
68.18 percentage of participants
Interval 45.06 to 91.3
66.92 percentage of participants
Interval 49.21 to 84.64
82.50 percentage of participants
Interval 70.72 to 94.28
81.82 percentage of participants
Interval 68.66 to 94.98
79.62 percentage of participants
Interval 65.04 to 94.19
75.62 percentage of participants
Interval 59.87 to 91.37
87.50 percentage of participants
Interval 64.58 to 100.0

SECONDARY outcome

Timeframe: From first occurrence of a documented OR until the time of documented PD or death (Up to 50.4 months)

Population: Efficacy population=all participants who received at least 1 dose of each drug for their assigned treatment regimen. Overall number analyzed=all participants who achieved OR. Cohort 1 with 'Atezolizumab (control arm)' was closed during the study conduct \& was reactivated with 'Atezo + Tira' as a new comparator arm. Comparative statistics are not presented for Atezo + Tira arm \& Atezo + CEA-TCB arms (Cohorts 1 \& 2) due to the small sample size (N=1), which precludes any meaningful conclusion.

DOR was defined as the time from the first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurred first as per investigator assessment using RECIST v1.1. DOR was calculated for participants who had a best confirmed OR of CR/PR. CR and PR were defined as outlined in the description for ORR outcome measure. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, DOR was censored at the day of the last tumor assessment. K-M method was used to estimate DOR. The participant in the 'S1C2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

Outcome measures

Outcome measures
Measure
Stage 1 Cohort 1: Control (Atezolizumab)
n=1 Participants
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Control (Docetaxel)
n=8 Participants
Participants received docetaxel 75 mg/m\^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CPI-444
n=1 Participants
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Docetaxel + Atezolizumab
n=1 Participants
Participants received docetaxel 75 mg/m\^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
n=2 Participants
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
n=8 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy
n=6 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + SG
n=2 Participants
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Evolocumab
n=1 Participants
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Camonsertib
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 2 Cohort 1: Carboplatin + Pemetrexed + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m\^2, IV infusions on Day 1 of each cycle and carboplatin AUC 6 mg/mL/min (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Docetaxel + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m\^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Atezolizumab + Linagliptin
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST V1.1
30.39 months
95% CI was not estimable due to an insufficient number of participants with events.
7.03 months
Interval 3.48 to
Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
5.36 months
95% CI was not estimable due to an insufficient number of participants with events.
19.09 months
95% CI was not estimable due to an insufficient number of participants with events.
16.20 months
95% CI was not estimable due to an insufficient number of participants with events.
4.17 months
Interval 1.41 to
Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
14.54 months
Interval 5.13 to 16.62
20.99 months
Interval 11.1 to
Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
5.36 months
Interval 4.17 to
Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
23.26 months
95% CI was not estimable due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to 50.4 months

Population: Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

DC was defined as stable disease (SD) for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1 Disease control rate (DCR) was defined as the percentage of participants with DC. CR was defined as the disappearance of all target \& non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Percentages have been rounded off.

Outcome measures

Outcome measures
Measure
Stage 1 Cohort 1: Control (Atezolizumab)
n=3 Participants
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Control (Docetaxel)
n=61 Participants
Participants received docetaxel 75 mg/m\^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
n=5 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
n=1 Participants
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=15 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CPI-444
n=15 Participants
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Docetaxel + Atezolizumab
n=16 Participants
Participants received docetaxel 75 mg/m\^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
n=30 Participants
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
n=40 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy
n=36 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + SG
n=30 Participants
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Evolocumab
n=31 Participants
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Camonsertib
n=8 Participants
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 2 Cohort 1: Carboplatin + Pemetrexed + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m\^2, IV infusions on Day 1 of each cycle and carboplatin AUC 6 mg/mL/min (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Docetaxel + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m\^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Atezolizumab + Linagliptin
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST V1.1
33.3 percentage of participants
Interval 0.84 to 90.57
57.4 percentage of participants
Interval 44.06 to 69.96
40.0 percentage of participants
Interval 5.27 to 85.34
100 percentage of participants
Interval 2.5 to 100.0
0 percentage of participants
Interval 0.0 to 97.5
33.3 percentage of participants
Interval 11.82 to 61.62
100 percentage of participants
Interval 2.5 to 100.0
40.0 percentage of participants
Interval 16.34 to 67.71
56.3 percentage of participants
Interval 29.88 to 80.25
36.7 percentage of participants
Interval 19.93 to 56.14
65.0 percentage of participants
Interval 48.32 to 79.37
69.4 percentage of participants
Interval 51.89 to 83.65
66.7 percentage of participants
Interval 47.19 to 82.71
41.9 percentage of participants
Interval 24.55 to 60.92
37.5 percentage of participants
Interval 8.52 to 75.51

SECONDARY outcome

Timeframe: From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months)

Population: Safety-evaluable population included all participants who received any amount of study treatment. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAEs = Serious AEs; AESIs = Adverse Events of Special Interest.

Outcome measures

Outcome measures
Measure
Stage 1 Cohort 1: Control (Atezolizumab)
n=3 Participants
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Control (Docetaxel)
n=61 Participants
Participants received docetaxel 75 mg/m\^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
n=5 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
n=1 Participants
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=15 Participants
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
n=1 Participants
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CPI-444
n=15 Participants
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Docetaxel + Atezolizumab
n=16 Participants
Participants received docetaxel 75 mg/m\^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
n=30 Participants
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
n=40 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy
n=43 Participants
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + SG
n=30 Participants
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Evolocumab
n=31 Participants
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Camonsertib
n=8 Participants
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 2 Cohort 1: Carboplatin + Pemetrexed + Atezolizumab
n=2 Participants
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m\^2, IV infusions on Day 1 of each cycle and carboplatin AUC 6 mg/mL/min (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Docetaxel + Atezolizumab
n=32 Participants
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m\^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Atezolizumab + Linagliptin
n=20 Participants
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stages 1 and 2: Number of Participants With Adverse Events (AEs)
3 Participants
60 Participants
5 Participants
1 Participants
1 Participants
15 Participants
1 Participants
15 Participants
16 Participants
30 Participants
38 Participants
42 Participants
30 Participants
30 Participants
8 Participants
2 Participants
31 Participants
19 Participants

Adverse Events

Stage 1 Cohort 1: Control (Atezolizumab)

Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths

Stage 1 Cohort 1: Atezolizumab + Cobimetinib

Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths

Stage 1 Cohort 1: Atezolizumab + CEA-TCB

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

Stage 1 Cohort 1: Atezolizumab + Tiragolumab

Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths

Stage 1 Cohort 2: Control (Docetaxel)

Serious events: 20 serious events
Other events: 58 other events
Deaths: 36 deaths

Stage 1 Cohort 2: Atezolizumab + Cobimetinib

Serious events: 8 serious events
Other events: 13 other events
Deaths: 10 deaths

Stage 1 Cohort 2: Atezolizumab + CEA-TCB

Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths

Stage 1 Cohort 2: Atezolizumab + CPI-444

Serious events: 8 serious events
Other events: 14 other events
Deaths: 10 deaths

Stage 1 Cohort 2: Docetaxel + Atezolizumab

Serious events: 5 serious events
Other events: 16 other events
Deaths: 10 deaths

Stage 1 Cohort 2: Atezolizumab + Ipatasertib

Serious events: 13 serious events
Other events: 30 other events
Deaths: 14 deaths

Stage 1 Cohort 2: Atezolizumab + Bevacizumab

Serious events: 13 serious events
Other events: 36 other events
Deaths: 22 deaths

Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy

Serious events: 17 serious events
Other events: 41 other events
Deaths: 23 deaths

Stage 1 Cohort 2: Atezolizumab + SG

Serious events: 14 serious events
Other events: 30 other events
Deaths: 19 deaths

Stage 1 Cohort 2: Atezolizumab + Evolocumab

Serious events: 10 serious events
Other events: 29 other events
Deaths: 25 deaths

Stage 1 Cohort 2: Atezolizumab + Camonsertib

Serious events: 4 serious events
Other events: 8 other events
Deaths: 4 deaths

Stage 2 Cohort 1: Carboplatin + Pemetrexed + Atezolizumab

Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths

Stage 2 Cohort 2: Docetaxel + Atezolizumab

Serious events: 13 serious events
Other events: 30 other events
Deaths: 29 deaths

Stage 2 Cohort 2: Atezolizumab + Linagliptin

Serious events: 6 serious events
Other events: 18 other events
Deaths: 19 deaths

Serious adverse events

Serious adverse events
Measure
Stage 1 Cohort 1: Control (Atezolizumab)
n=3 participants at risk
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
n=5 participants at risk
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
n=1 participants at risk
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
n=1 participants at risk
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
Stage 1 Cohort 2: Control (Docetaxel)
n=61 participants at risk
Participants received docetaxel 75 mg/m\^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=15 participants at risk
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
n=1 participants at risk
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CPI-444
n=15 participants at risk
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Docetaxel + Atezolizumab
n=16 participants at risk
Participants received docetaxel 75 mg/m\^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
n=30 participants at risk
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
n=40 participants at risk
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy
n=43 participants at risk
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + SG
n=30 participants at risk
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Evolocumab
n=31 participants at risk
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Camonsertib
n=8 participants at risk
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 2 Cohort 1: Carboplatin + Pemetrexed + Atezolizumab
n=2 participants at risk
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m\^2, IV infusions on Day 1 of each cycle and carboplatin AUC 6 mg/mL/min (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Docetaxel + Atezolizumab
n=32 participants at risk
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m\^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Atezolizumab + Linagliptin
n=20 participants at risk
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
General disorders
Pyrexia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
2/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Hepatobiliary disorders
Cholecystitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Hepatobiliary disorders
Drug-induced liver injury
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Hepatobiliary disorders
Gallbladder rupture
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Immune system disorders
Cytokine release syndrome
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Abdominal infection
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Arthritis infective
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
COVID-19
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
COVID-19 pneumonia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Cellulitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Encephalitis herpes
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Enterocolitis infectious
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Infection
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Influenza
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Large intestine infection
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Lower respiratory tract infection
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Neutropenic sepsis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Osteomyelitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Pneumonia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.8%
6/61 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Pneumonia aspiration
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Respiratory tract infection
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Sepsis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Septic shock
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Skin infection
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Upper respiratory tract infection
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Urinary tract infection
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Urosepsis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Injury, poisoning and procedural complications
Accidental overdose
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Injury, poisoning and procedural complications
Femur fracture
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Injury, poisoning and procedural complications
Hip fracture
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Injury, poisoning and procedural complications
Procedural pneumothorax
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Injury, poisoning and procedural complications
Radiation necrosis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Injury, poisoning and procedural complications
Spinal fracture
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Injury, poisoning and procedural complications
Wound dehiscence
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Blood creatinine increased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Lipase increased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Platelet count decreased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Transaminases increased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Dehydration
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Malnutrition
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Cauda equina syndrome
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Cerebral infarction
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Dizziness
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Embolic cerebral infarction
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Encephalitis autoimmune
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Hepatic encephalopathy
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Spinal cord compression
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Syncope
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Psychiatric disorders
Completed suicide
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Renal and urinary disorders
Acute kidney injury
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Renal and urinary disorders
Nephritis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Renal and urinary disorders
Renal failure
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Renal and urinary disorders
Renal tubular necrosis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Bronchial fistula
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.9%
3/61 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.9%
3/61 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Blister
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Vascular disorders
Capillary leak syndrome
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Vascular disorders
Deep vein thrombosis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Vascular disorders
Embolism
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Vascular disorders
Hypotension
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Vascular disorders
Lymphoedema
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Vascular disorders
Superior vena cava syndrome
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Blood and lymphatic system disorders
Anaemia
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Cardiac disorders
Acute myocardial infarction
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Cardiac disorders
Atrial fibrillation
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Cardiac disorders
Atrial flutter
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Cardiac disorders
Atrial tachycardia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Cardiac disorders
Cardiac failure
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Cardiac disorders
Cardiogenic shock
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Endocrine disorders
Adrenal insufficiency
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Endocrine disorders
Inappropriate antidiuretic hormone secretion
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Eye disorders
Retinal vein occlusion
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Eye disorders
Serous retinal detachment
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Abdominal pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Colitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Constipation
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Diarrhoea
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Dysphagia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Enteritis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Gastric perforation
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Gastric ulcer
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Gastritis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Gastrointestinal obstruction
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Ileus paralytic
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Intestinal perforation
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Vomiting
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Asthenia
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Death
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Fatigue
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
General physical health deterioration
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Implant site haematoma
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Oedema peripheral
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.

Other adverse events

Other adverse events
Measure
Stage 1 Cohort 1: Control (Atezolizumab)
n=3 participants at risk
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
n=5 participants at risk
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
n=1 participants at risk
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
n=1 participants at risk
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
Stage 1 Cohort 2: Control (Docetaxel)
n=61 participants at risk
Participants received docetaxel 75 mg/m\^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=15 participants at risk
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
n=1 participants at risk
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + CPI-444
n=15 participants at risk
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Docetaxel + Atezolizumab
n=16 participants at risk
Participants received docetaxel 75 mg/m\^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
n=30 participants at risk
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
n=40 participants at risk
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy
n=43 participants at risk
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + SG
n=30 participants at risk
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Evolocumab
n=31 participants at risk
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 1 Cohort 2: Atezolizumab + Camonsertib
n=8 participants at risk
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Stage 2 Cohort 1: Carboplatin + Pemetrexed + Atezolizumab
n=2 participants at risk
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m\^2, IV infusions on Day 1 of each cycle and carboplatin AUC 6 mg/mL/min (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Docetaxel + Atezolizumab
n=32 participants at risk
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m\^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2 Cohort 2: Atezolizumab + Linagliptin
n=20 participants at risk
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Gastrointestinal disorders
Diarrhoea
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
40.0%
2/5 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
32.8%
20/61 • Number of events 27 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
46.7%
7/15 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
37.5%
6/16 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
63.3%
19/30 • Number of events 42 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
22.5%
9/40 • Number of events 13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.9%
9/43 • Number of events 12 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
43.3%
13/30 • Number of events 18 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
22.6%
7/31 • Number of events 11 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
25.0%
2/8 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
25.0%
8/32 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
2/20 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Dry mouth
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
2/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Dyspepsia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Dysphagia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.9%
3/61 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Intestinal dilatation
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Lip dry
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Mouth haemorrhage
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Mouth ulceration
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Nausea
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
19.7%
12/61 • Number of events 14 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
26.7%
4/15 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
25.0%
4/16 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
33.3%
10/30 • Number of events 10 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.5%
3/40 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.3%
4/43 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
40.0%
12/30 • Number of events 17 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
4/8 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
3/20 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Stomatitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
8.2%
5/61 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.4%
3/32 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Toothache
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Vomiting
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.9%
3/61 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
25.0%
4/16 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
26.7%
8/30 • Number of events 10 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.0%
3/43 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
6/30 • Number of events 13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Administration site extravasation
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Asthenia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
39.3%
24/61 • Number of events 33 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
3/15 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
31.2%
5/16 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
36.7%
11/30 • Number of events 19 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
5/40 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
39.5%
17/43 • Number of events 20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
26.7%
8/30 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.9%
4/31 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
25.0%
2/8 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
43.8%
14/32 • Number of events 21 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Chest pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.9%
3/61 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
3/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.0%
3/43 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.9%
4/31 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Chills
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Fatigue
66.7%
2/3 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.0%
11/61 • Number of events 13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
25.0%
4/16 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
17.5%
7/40 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
11.6%
5/43 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
23.3%
7/30 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.9%
4/31 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
25.0%
2/8 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
2/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Gait disturbance
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Infusion site pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Localised oedema
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Mucosal dryness
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Mucosal inflammation
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.6%
4/61 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
23.3%
7/30 • Number of events 10 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.8%
6/32 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Non-cardiac chest pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Oedema peripheral
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
40.0%
2/5 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
14.8%
9/61 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.3%
4/43 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.4%
3/32 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
3/20 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Peripheral swelling
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Pyrexia
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.8%
6/61 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.8%
3/16 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
6/30 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
5/40 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.0%
3/43 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
6/30 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
3/20 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Swelling
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
General disorders
Swelling face
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Hepatobiliary disorders
Biliary obstruction
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Hepatobiliary disorders
Cholecystitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Hepatobiliary disorders
Hepatic pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Immune system disorders
Seasonal allergy
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Abscess limb
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Arthritis bacterial
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Bronchitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
COVID-19
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
2/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.5%
3/40 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
4/30 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Conjunctivitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Escherichia infection
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Folliculitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Furuncle
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Gastrointestinal viral infection
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Gingivitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Herpes zoster
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Infection
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Lower respiratory tract infection
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
2/20 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Nasopharyngitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Oral candidiasis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Blood and lymphatic system disorders
Anaemia
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
34.4%
21/61 • Number of events 23 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
26.7%
4/15 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
33.3%
5/15 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
31.2%
5/16 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
23.3%
7/30 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
11.6%
5/43 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
46.7%
14/30 • Number of events 28 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
19.4%
6/31 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
87.5%
7/8 • Number of events 14 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
2/2 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
31.2%
10/32 • Number of events 27 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
3/20 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Blood and lymphatic system disorders
Hyperleukocytosis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
2/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
5/40 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
23.3%
10/43 • Number of events 14 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.9%
4/31 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.4%
3/32 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Blood and lymphatic system disorders
Monocytosis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
8.2%
5/61 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
30.0%
9/30 • Number of events 32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.8%
6/32 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.5%
3/40 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Cardiac disorders
Atrial fibrillation
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Cardiac disorders
Atrial flutter
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Ear and labyrinth disorders
Hypoacusis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Ear and labyrinth disorders
Tinnitus
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Ear and labyrinth disorders
Vertigo
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Endocrine disorders
Hyperthyroidism
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Endocrine disorders
Hypothyroidism
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Eye disorders
Blepharitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Eye disorders
Cataract
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Eye disorders
Central serous chorioretinopathy
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Eye disorders
Diplopia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Eye disorders
Dry eye
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Eye disorders
Eyelid oedema
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Eye disorders
Lacrimation increased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.8%
6/61 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Eye disorders
Macular thickening
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Eye disorders
Ocular hyperaemia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Eye disorders
Photopsia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Eye disorders
Vision blurred
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Eye disorders
Visual acuity reduced
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Abdominal distension
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Abdominal pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
11.5%
7/61 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.8%
3/16 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
22.5%
9/40 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
14.0%
6/43 • Number of events 12 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
14.0%
6/43 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Chapped lips
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Cheilitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Gastrointestinal disorders
Constipation
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
40.0%
2/5 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
2/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
3/15 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
4/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
6/40 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
14.0%
6/43 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
36.7%
11/30 • Number of events 14 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
19.4%
6/31 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
25.0%
2/8 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
2/2 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
4/20 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Otitis media
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Pneumonia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.9%
3/61 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.9%
4/31 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
25.0%
2/8 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Pneumonia cytomegaloviral
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Rash pustular
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Respiratory tract infection
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.4%
3/32 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Rhinitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Skin candida
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Upper respiratory tract infection
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Infections and infestations
Urinary tract infection
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.0%
3/43 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Injury, poisoning and procedural complications
Fall
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Injury, poisoning and procedural complications
Inappropriate schedule of product administration
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Injury, poisoning and procedural complications
Medication error
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Injury, poisoning and procedural complications
Radiation pneumonitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Injury, poisoning and procedural complications
Rib fracture
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Injury, poisoning and procedural complications
Skin abrasion
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Alanine aminotransferase increased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
40.0%
2/5 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
2/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
26.7%
4/15 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.5%
3/40 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.3%
4/43 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
16.7%
5/30 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
16.1%
5/31 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Amylase increased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
3/15 • Number of events 16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
5/40 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.0%
3/43 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 11 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Aspartate aminotransferase increased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
60.0%
3/5 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.6%
4/61 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
26.7%
4/15 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
3/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
22.5%
9/40 • Number of events 10 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
16.3%
7/43 • Number of events 10 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
4/30 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.9%
4/31 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Blood alkaline phosphatase increased
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
5/40 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.3%
4/43 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
4/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Blood creatine phosphokinase increased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Blood creatinine increased
33.3%
1/3 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
3/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
6/40 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
14.0%
6/43 • Number of events 10 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Blood glucose increased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Blood lactate dehydrogenase increased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Blood thyroid stimulating hormone decreased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Blood thyroid stimulating hormone increased
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Body temperature increased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
C-reactive protein increased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
2/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Ejection fraction decreased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Electrocardiogram QT prolonged
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Gamma-glutamyltransferase increased
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
6/40 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.3%
4/43 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Haemoglobin decreased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Intraocular pressure increased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Lipase increased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
6/40 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.3%
4/43 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 11 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Neutrophil count decreased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.6%
4/61 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
6/30 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Platelet count decreased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
Weight decreased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
40.0%
2/5 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
3/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.8%
3/16 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.5%
3/40 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.3%
4/43 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
3/30 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Investigations
White blood cell count decreased
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
3/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Decreased appetite
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
19.7%
12/61 • Number of events 17 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
43.8%
7/16 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
4/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
22.5%
9/40 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
16.3%
7/43 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
6/30 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.7%
3/31 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
37.5%
3/8 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
21.9%
7/32 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
3/20 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Dehydration
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
2/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.8%
3/16 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Hypercholesterolaemia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.5%
3/40 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.9%
3/61 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Hyperkalaemia
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.5%
3/40 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Hypertriglyceridaemia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Hypoalbuminaemia
66.7%
2/3 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.8%
6/61 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
3/15 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
4/40 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
11.6%
5/43 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.9%
4/31 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Hypokalaemia
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.0%
3/43 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
3/30 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
2/61 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.8%
3/16 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
11.6%
5/43 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
4/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
2/20 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.3%
4/43 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
3/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.3%
4/43 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Metabolism and nutrition disorders
Iron deficiency
33.3%
1/3 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Arthralgia
66.7%
2/3 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
8.2%
5/61 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.8%
3/16 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
22.5%
9/40 • Number of events 15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
23.3%
10/43 • Number of events 24 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
4/30 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
16.1%
5/31 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.8%
6/32 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
2/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
5/40 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
14.0%
6/43 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
26.7%
8/30 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.7%
3/31 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Clubbing
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Joint swelling
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
11.6%
5/43 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Muscle twitching
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
11.5%
7/61 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.8%
3/16 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.5%
3/40 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.6%
8/43 • Number of events 10 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.4%
3/32 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.3%
4/43 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
3/20 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.0%
3/43 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Dizziness
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.6%
4/61 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
6/40 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.0%
3/43 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
4/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Dysgeusia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.6%
4/61 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.6%
5/32 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Headache
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
40.0%
2/5 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
2/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
6/30 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
4/40 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
14.0%
6/43 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
4/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
2/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Hyperammonaemic encephalopathy
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Hypoaesthesia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Motor dysfunction
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Neuralgia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Neuropathy peripheral
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
14.8%
9/61 • Number of events 12 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
25.0%
4/16 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
4/32 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Neurotoxicity
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.6%
4/61 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.4%
3/32 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Paraesthesia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
2/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Post herpetic neuralgia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Somnolence
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Spinal cord compression
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Syncope
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Tremor
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Nervous system disorders
Vocal cord paralysis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Product Issues
Device occlusion
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Psychiatric disorders
Anger
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Psychiatric disorders
Anxiety
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Psychiatric disorders
Confusional state
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Psychiatric disorders
Depression
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Psychiatric disorders
Insomnia
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.6%
4/61 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.5%
3/40 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.0%
3/43 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
4/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
3/20 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Renal and urinary disorders
Dysuria
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
40.0%
2/5 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Renal and urinary disorders
Haematuria
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.0%
3/43 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Renal and urinary disorders
Micturition urgency
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Renal and urinary disorders
Proteinuria
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
6/40 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
23.3%
10/43 • Number of events 11 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Renal and urinary disorders
Renal failure
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Renal and urinary disorders
Renal impairment
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Renal and urinary disorders
Urinary hesitation
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Reproductive system and breast disorders
Benign prostatic hyperplasia
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Reproductive system and breast disorders
Pelvic pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Reproductive system and breast disorders
Prostatomegaly
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
16.4%
10/61 • Number of events 11 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
6/30 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
6/40 • Number of events 12 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.6%
8/43 • Number of events 11 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
4/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.9%
4/31 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
37.5%
3/8 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.6%
5/32 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
2/20 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.9%
3/61 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
5/40 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.3%
4/43 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
19.7%
12/61 • Number of events 14 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
3/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
40.0%
6/15 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.8%
3/16 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
8/40 • Number of events 14 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
14.0%
6/43 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
23.3%
7/30 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.9%
4/31 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
62.5%
5/8 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.4%
3/32 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
3/20 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
2/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.8%
3/16 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
4/40 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
2/61 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
3/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.9%
4/31 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Nasal dryness
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.5%
2/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
2/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.9%
4/31 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
11.5%
7/61 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
4/40 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
9.7%
3/31 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Rales
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
2/61 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Respiratory, thoracic and mediastinal disorders
Throat irritation
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
32.8%
20/61 • Number of events 20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
37.5%
6/16 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
15/30 • Number of events 17 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
31.2%
10/32 • Number of events 11 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
40.0%
2/5 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.9%
3/61 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.8%
3/16 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
7.0%
3/43 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Nail discolouration
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.6%
4/61 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Nail disorder
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
2/16 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Neurodermatitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.5%
1/8 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Onycholysis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
8.2%
5/61 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
1/5 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.9%
3/61 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
3/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
13.3%
2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
25.0%
4/16 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
10.0%
4/40 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
16.3%
7/43 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
36.7%
11/30 • Number of events 15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
12.9%
4/31 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
2/32 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
15.0%
3/20 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Rash
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
40.0%
2/5 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.6%
4/61 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
26.7%
4/15 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
16.7%
5/30 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
2/40 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
18.6%
8/43 • Number of events 10 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
20.0%
6/30 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
50.0%
1/2 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Rash erythematous
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Rash maculo-papular
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Skin atrophy
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Skin exfoliation
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
100.0%
1/1 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Skin lesion
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Skin ulcer
33.3%
1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Skin and subcutaneous tissue disorders
Stasis dermatitis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Vascular disorders
Deep vein thrombosis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Vascular disorders
Flushing
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/16 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.3%
1/43 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Vascular disorders
Hypertension
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
40.0%
2/5 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
17.5%
7/40 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
11.6%
5/43 • Number of events 13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.3%
1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Vascular disorders
Hypotension
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
2.5%
1/40 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
4.7%
2/43 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.7%
2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.2%
1/31 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
3.1%
1/32 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
5.0%
1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Vascular disorders
Jugular vein thrombosis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
1.6%
1/61 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
Vascular disorders
Thrombosis
0.00%
0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/61 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
6.2%
1/16 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/40 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/43 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/31 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/32 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
0.00%
0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment. All-cause Mortality: Randomized population included all participants randomized to each treatment arm. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Results disclosure agreements

  • Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
  • Publication restrictions are in place

Restriction type: OTHER